A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China

Sponsor

China Academy of Chinese Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01812876

Collaborator

(none)

30,000

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.

Condition or Disease	Intervention/Treatment	Phase
Gastric Carcinoma Carcinoma of the Lungs

Detailed Description

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014.

Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction [to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng]
All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge. Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shenqifuzheng

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients using Shenqifuzheng injection from 2013 to 2014

Exclusion Criteria:

none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China Academy of Chinese Medical Sciences

Investigators

Principal Investigator: Xie M Yan, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences

ClinicalTrials.gov Identifier:

NCT01812876

Other Study ID Numbers:

2009ZX09502-030-01

First Posted:

Mar 18, 2013

Last Update Posted:

Apr 16, 2013

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Carcinoma

Stomach Neoplasms

Lung Neoplasms

Study Results

No Results Posted as of Apr 16, 2013